Clinical Trial

The Gastric Bypass Stent System as a Treatment for Hepatic Fibrosis in Obese Patients in European Region

Recruiting
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Record status
This record was last updated May 8, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
Summary
The Gastric Bypass Stent System is intended to be used in weight loss treatment for obesity and holds potential as a non-invasive technique for managing hepatic fibrosis. This pilot, prospective, single-arm, clinical investigation aims to evaluate the safety and performance of the Gastric Bypass Stent System for hepatic fibrosis treatment in Europe. This clinical investigation and the ongoing clinical investigation (Protocol number: BL-RD08-040) will be used to evaluate the safety and performance of the investigational device for the intended use.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-08-19; most recent amendment 2025-05-06.
Trial Details
NCT Number NCT06561529
Lead Sponsor MDCECRO LLC
Collaborators: Hangzhou Tangji Medical Technology Co., Ltd.
Conditions Fibrosis, Liver
Enrollment 10 participants
Start Date 2024-06-13
Primary Completion 2025-12 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-05-08